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Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design

Daniel Vt Catenacci1, Anteneh Tesfaye2, Mohamed Tejani3

  • 1University of Chicago Comprehensive Cancer Center, Chicago, IL, USA.

Future Oncology (London, England)
|May 17, 2019
PubMed

Insights

Bemarituzumab shows promise in treating advanced gastroesophageal cancer by targeting FGFR2b. This study evaluates its efficacy when combined with chemotherapy in previously untreated patients.

Area of Science:

  • Oncology
  • Gastroenterology
  • Immunotherapy

Background:

  • Bemarituzumab, an afucosylated monoclonal antibody targeting FGFR2b, has shown clinical activity in late-line gastric cancer.
  • FGFR2b overexpression is a targetable biomarker in advanced gastroesophageal cancer.

Purpose of the Study:

  • To evaluate the efficacy and safety of bemarituzumab in combination with mFOLFOX6 chemotherapy.
  • To assess bemarituzumab's role in previously untreated, FGFR2b-overexpressing advanced gastroesophageal cancer.

Main Methods:

  • Global, randomized, double-blind, placebo-controlled Phase III trial (FIGHT trial).
  • Patients randomized to mFOLFOX6 plus bemarituzumab or mFOLFOX6 plus placebo.
  • Eligibility based on FGFR2b protein overexpression (immunohistochemistry) or FGFR2 gene amplification (circulating tumor DNA).

Main Results:

  • Primary endpoint: Overall survival.
  • Secondary endpoints: Progression-free survival, objective response rate, and safety.

Conclusions:

  • The FIGHT trial aims to establish bemarituzumab as a new standard of care for FGFR2b-positive advanced gastroesophageal cancer.
  • Results will inform future treatment strategies targeting FGFR2b in this patient population.
Keywords:
FGFR2 amplification bemarituzumabPhase III study designgastric and esophageal adenocarcinoma

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